The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Bicore Smartcath Intratracheal Catheter.
| Device ID | K935788 |
| 510k Number | K935788 |
| Device Name: | BICORE SMARTCATH INTRATRACHEAL CATHETER |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | BICORE MONITORING SYSTEMS 2-A FARADAY Irvine, CA 92718 |
| Contact | Muir S Meinhold |
| Correspondent | Muir S Meinhold BICORE MONITORING SYSTEMS 2-A FARADAY Irvine, CA 92718 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1995-07-03 |